Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.
详细描述
Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC.
Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%.
The secondary hypothesis is that the intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).
Patients will be recruited from the outpatient clinic of Skin Care Network London.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment.
- •Patient willing and able to give informed consent
排除标准
- •Recurrent or other higher-risk BCC
- •Patient with basal cell naevus syndrome
- •Patient treated with hedgehog inhibitor medication (vismodegib)
- •Patient not suitable for diagnostic biopsy
- •Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
- •Patient with co-morbidities such as other skin disease
结局指标
主要结局
Sensitivity and Specificity
时间窗: During exam (biopsy results typically available within one week).
Specificity \& Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology
次要结局
- intra- & inter-observer agreement for interpreting the RCM images(6 months)